(77 days)
The ISOLA® Growing Spine System is indicated for patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The ISOLA® Growing Spine System may be used with any cleared traditional ISOLA® Spine System 3/16 inch rod constructs.
The EXPEDIUM® Growing Spine System is indicated for patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The EXPEDIUM® Growing System may be used with any cleared traditional 4.5 and 5.5 EXPEDIUM® Spine Systems. The EXPEDIUM® Growing Spine System is not intended to be used with 4.0mm diameter screws.
The ISOLA and EXPEDIUM Growing Spine Systems consist of an assortment of connectors designed to convert a traditional fusion construct into a non-fusion growth enabling construct that can be surgically lengthened on a periodic basis as the patient grows. The ISOLA and EXPEDIUM Growing Spine Systems' components are manufactured from titanium alloy and stainless steel and are designed to interact with constructs consisting of rods ranging in diameter from 4.5 to 5.5mm, hooks, screws, offset connectors, and cross connectors. The ISOLA and EXPEDIUM Growing Spine Systems are intended for use only with ISOLA (3/16 inch rod diameter) and EXPEDIUM Spinal Systems (4.5 and 5.5mm rod diameter) fusion constructs for cleared pediatric use.
This document describes the ISOLA® and EXPEDIUM® Growing Spine Systems which are surgical devices, not AI/ML software. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies for AI/ML performance is not applicable to this submission.
The provided document, K141509, is a 510(k) premarket notification for medical devices. The relevant performance data for this type of device typically involves mechanical and material testing, not clinical studies in the context of AI/ML performance.
However, based on the information provided in the document, here's what can be extracted regarding the device's assessment:
1. Acceptance Criteria and Reported Device Performance:
The document broadly states that "Performance data per ASTM F 1717 (static and dynamic compression bending and static torsion) were submitted to characterize the subject ISOLA and EXPEDIUM Growing Spine Systems components addressed in this notification."
- Acceptance Criteria (Implied): The acceptance criteria are implicitly based on meeting the standards outlined in ASTM F 1717 for static and dynamic compression bending and static torsion for spinal implant constructs. These standards define the mechanical properties and performance expectations for such devices. Specific numerical thresholds or pass/fail criteria are not detailed in this summary but would have been part of the full submission to the FDA.
- Reported Device Performance: The summary concludes that "Both the Performance Testing and Substantial Equivalence Justification demonstrate that the proposed device is substantially equivalent to the predicate devices." This indicates that the device met the performance requirements of ASTM F 1717 and demonstrated performance comparable to its predicate devices.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set: Not applicable in the context of AI/ML. For mechanical testing, the "sample size" would refer to the number of device components or constructs subjected to testing. This information is not provided in this summary but would be detailed in the full test reports.
- Data Provenance: Not applicable in the context of AI/ML. Mechanical test data is typically generated in a lab setting, not from patient data, and is therefore not "retrospective or prospective" in the medical study sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable. "Ground truth" in the AI/ML sense (e.g., expert labels on medical images) is not relevant for the mechanical testing of a surgical implant.
4. Adjudication Method for the Test Set:
- Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. This is not an AI/ML device.
6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study:
- Not applicable. This is not an AI/ML device.
7. Type of Ground Truth Used:
- Not applicable for AI/ML. For mechanical performance, the "ground truth" is defined by the objective physical measurements and engineering specifications outlined in the ASTM F 1717 standard.
8. Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. This is not an AI/ML device.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.